U.S. patent number 5,935,098 [Application Number 08/772,707] was granted by the patent office on 1999-08-10 for apparatus and method for accessing and manipulating the uterus.
This patent grant is currently assigned to Conceptus, Inc.. Invention is credited to Michael W. Blaisdell, Thomas A. Kramer, Piush Vidyarthi.
United States Patent |
5,935,098 |
Blaisdell , et al. |
August 10, 1999 |
Apparatus and method for accessing and manipulating the uterus
Abstract
A uterine access catheter system comprises an inner catheter and
a sleeve catheter slidably disposed over the inner catheter. The
inner catheter is a balloon catheter having an elastomeric balloon
near its distal end and suitable for performing
hysterosalpingography procedures. The sleeve catheter includes an
occluding member near its distal end, and the inner catheter and
outer catheter may be used together to seal against and engage the
cervix of a patient undergoing hysterosalpingography or other
genealogical procedures. The sleeve catheter is locked to the inner
catheter, typically relative by relative rotation of the two
catheters. The occluding member may be detachable and reusable.
Means may be provided for drawing a vacuum between the occluding
member and the balloon to further engage the cervical os.
Inventors: |
Blaisdell; Michael W.
(Sylvania, OH), Vidyarthi; Piush (San Francisco, CA),
Kramer; Thomas A. (San Carlos, CA) |
Assignee: |
Conceptus, Inc. (San Carlos,
CA)
|
Family
ID: |
25095957 |
Appl.
No.: |
08/772,707 |
Filed: |
December 23, 1996 |
Current U.S.
Class: |
604/515; 606/193;
604/103.01 |
Current CPC
Class: |
A61M
25/04 (20130101); A61F 6/18 (20130101); A61B
17/4241 (20130101); A61M 2025/0006 (20130101); A61M
2025/1054 (20130101) |
Current International
Class: |
A61M
25/02 (20060101); A61F 6/18 (20060101); A61F
6/00 (20060101); A61M 25/04 (20060101); A61B
17/42 (20060101); A61M 031/00 (); A61M
025/00 () |
Field of
Search: |
;606/1,191,193,194,195,158 ;604/55,174,96-101,178 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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|
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730355 |
|
Apr 1978 |
|
SU |
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WO 96/22122 |
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Jul 1996 |
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WO |
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Other References
Product Brochure ZUMI-4.5 , BEI Medical Systems, Inc..
|
Primary Examiner: Buiz; Michael
Assistant Examiner: Lewis; William W.
Attorney, Agent or Firm: Townsend and Townsend and Crew
LLP
Parent Case Text
The subject matter of the present application is related to
copending application Ser. No. 08/772,395 (attorney docket No.
16355-003100), filed on the same day as the present application,
the full disclosure of which is incorporated herein by reference.
Claims
What is claimed is:
1. A method for performing hysterosalpingography on a patient, said
method comprising:
providing a catheter assembly including (1) an inner catheter
having a balloon near its distal end and (2) a sleeve catheter
disposed coaxially over the inner catheter, wherein the sleeve
catheter includes an atraumatic occluding member near its distal
end;
introducing the catheter assembly through the patient's vagina so
that the balloon is positioned past the cervix and in the uterus
while the occluding member on the sleeve catheter engages outside
the cervix;
inflating the balloon to seal against the cervix;
introducing contrast media through the inner catheter into the
uterus;
imaging the uterus; and
advancing a distal end of the sleeve catheter over the inner
catheter through the cervix and withdrawing the inner catheter from
the sleeve catheter to leave an access lumen in the sleeve catheter
through the cervix into the uterus.
2. A method as in claim 1, further comprising:
introducing a uterine catheter through the lumen of the sleeve
catheter and into the uterus after the sleeve catheter has been
advanced into the uterus and the inner catheter removal from the
sleeve catheter; and
guiding a distal end of the uterine catheter to the os at the
entrance to a fallopian tube.
3. A method as in claim 2, further comprising:
passing a fallopian catheter through a lumen of the uterine
catheter and into the fallopian tube.
4. A method as in claim 3, further comprising:
passing a falloposcope through a lumen of the fallopian catheter;
and
imaging the fallopian tube using the falloposcope.
5. A method as in claim 3, further comprising
introducing contrast media through the fallopian catheter into the
fallopian tube; and
imaging the fallopian tube.
6. A method as in claim 1, further comprising infusing of
aspirating a fluid or material through the sleeve catheter into the
uterus after the sleeve catheter has been advanced into the uterus
and the inner catheter removed from the lumen of the sleeve
catheter.
7. A method as in claim 1, wherein the catheter system further
comprises a stiffening rod that is removably received in a lumen of
the inner catheter, wherein the stiffening rod is in place when the
catheter system is introduced through the vagina and cervix and is
removed prior to introducing contact media into the uterus.
8. A method as in claim 7, wherein the stiffening rod is malleable
and further comprising shaping a portion of the stiffening rod so
that the inner catheter assumes a shape selected to match the
patient's anatomy.
9. A uterine access catheter system comprising:
an inner catheter having a proximal end, a distal end, an access
lumen therebetween, and an inflatable balloon near the distal
end;
a sleeve catheter having a proximal end, a distal end, and a lumen
therebetween sized to slidably receive the inner catheter, wherein
the length of the sleeve catheter is less than the length of the
inner catheter by at least 5 cm so that the distal end of the inner
catheter can be introduced through a patient's cervix while the
distal end of the sleeve catheter remains outside of the cervix;
and
an occluding member on the distal end of the sleeve catheter
adapted to engage against the outside of a cervical os when the
inner catheter passes through the cervix and the sleeve catheter is
placed over the inner catheter.
10. A uterine access catheter system as in claim 9, wherein the
inner catheter further includes a hub at its proximal end, wherein
the sleeve catheter may be introduced and removed over the distal
end of the inner catheter.
11. A uterine access catheter system as in claim 10, wherein the
inner catheter has an outside diameter in the range from 1 mm to
2.5 mm and a lumen diameter in the range from 0.5 mm to 1.5 mm, a
length from 25 cm to 40 cm, and wherein the sleeve catheter has a
lumen diameter in the range from 2 mm to 4 mm, an outside diameter
in the range from 3 mm to 4.5 mm, and a length in the range from 15
cm to 25 cm.
12. A uterine access catheter system, as in claim 11, wherein the
distal balloon is elastomeric and can be inflated to a width in the
range from 10 mm to 15 mm.
13. A uterine access catheter system, as in claim 9, wherein the
inner catheter is composed of a soft material having a hardness in
the range from 65D to 75D, and the sleeve catheter is composed of a
material having a hardness in the range from 70D to 80D.
14. A uterine access catheter system as in claim 9, wherein the
stiffening rod is malleable over at least a distal portion
thereof.
15. A uterine access catheter system as in claim 9, wherein the
stiffening rod is resilient.
16. A uterine access catheter system as in claim 9, wherein the
sleeve catheter is more rigid than the inner catheter.
17. A uterine access catheter system as in claim 9, wherein the
sleeve catheter comprises a handle at its proximal end.
18. A uterine access catheter system as in claim 17, wherein the
handle comprises a connectable fitting.
19. A method for performing hysterosalpingography on a patient,
said method comprising:
providing a catheter assembly including (1) an inner catheter
having a balloon near its distal end and (2) a sleeve catheter
disposed coaxially over the inner catheter, wherein the sleeve
catheter includes an atraumatic occluding member near its distal
end;
introducing the catheter assembly through the patient's vagina so
that the balloon is positioned past the cervix and in the uterus
while the occluding member on the sleeve catheter engages outside
the cervix;
inflating the balloon to seal against the cervix;
introducing contrast media through the inner catheter into the
uterus;
imaging the uterus;
introducing a uterine catheter through the lumen of the sleeve
catheter and into the uterus after the sleeve catheter has been
advanced into the uterus and the inner catheter removal from the
sleeve catheter; and
guiding a distal end of the uterine catheter to the os at the
entrance to a fallopian tube
passing a falloposcope through a lumen of the fallopian catheter;
and
imaging the fallopian tube using the falloposcope.
20. A method as in claim 19, further comprising
introducing contrast media through the fallopian catheter into the
fallopian tube; and
imaging the fallopian tube.
21. A method as in claim 19, further comprising advancing the
sleeve catheter into the uterus; removing the inner catheter from
the lumen of the sleeve catheter; and infusing of aspirating a
fluid or material through the sleeve catheter into the uterus.
22. A method as in claim 19, wherein the catheter system further
comprises a stiffening rod that is removably received in a lumen of
the inner catheter, wherein the stiffening rod is in place when the
catheter system is introduced through the vagina and cervix and is
removed prior to introducing contact media into the uterus.
23. A method as in claim 22, wherein the stiffening rod is
malleable and further comprising shaping a portion of the
stiffening rod so that the inner catheter assumes a shape selected
to match the patient's anatomy.
24. A method for performing hysterosalpingography on a patient,
said method comprising:
providing a catheter assembly including (1) an inner catheter
having a balloon near its distal end, (2) a sleeve catheter
disposed coaxially over the inner catheter, wherein the sleeve
catheter includes an atraumatic occluding member near its distal
end, and (3) a stiffening rod that is removably received in a lumen
of the inner catheter;
introducing the catheter assembly through the patient's vagina with
the stiffening rod in place in the inner catheter lumen so that the
balloon is positioned past the cervix and in the uterus while the
occluding member on the sleeve catheter engages outside the
cervix;
inflating the balloon to seal against the cervix;
removing the stiffening rod; and
introducing contrast media through the inner catheter into the
uterus;
imaging the uterus.
25. A method as in claim 24, further comprising:
introducing a uterine catheter through the lumen of the sleeve
catheter and into the uterus after the sleeve catheter has been
advanced into the uterus and the inner catheter removal from the
sleeve catheter; and
guiding a distal end of the uterine catheter to the os at the
entrance to a fallopian tube.
26. A method as in claim 24, further comprising:
passing a falloposcope through a lumen of the fallopian catheter;
and
imaging the fallopian tube using the falloposcope.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to methods and apparatus
for accessing the uterus and optionally the fallopian tubes of a
patient. More particularly, the present invention relates to a
uterine access catheter system and method which provide for both
uterine access and manipulation.
Diseases of the fallopian tubes are a major cause of infertility
and tubal pregnancy. Until recently, diagnosis and treatment of
tubal disease has been hampered by the difficulty of accessing and
imaging the interior of the fallopian tubes in a least invasive
manner. Such difficulties, however, have been largely overcome by
the present availability of very small guidewires, catheters, and
fiberoptic viewing scopes, usually referred to as falloposcopes.
Particular systems and methods employing a hysteroscope in
combination with the guidewire and small diameter fallopian access
catheter for accessing and viewing the interior of the fallopian
tubes are described in Kerin et al. (1990) Fertil. Steril.
54:390-400 and J. Laparo. Endoscopic Surg. 1:47-56, and copending
patent application Ser. No. 08/207,475, assigned to the assignee of
the present application.
A common medical procedure for imaging the uterus and fallopian
tubes is referred to as hysterosalpingography. Such procedures rely
on injecting contrast media into the uterus and fallopian tubes
using a uterine access catheter having an elastomeric balloon near
its distal end for sealing against the cervix. The anatomical
structures of the uterus and fallopian tubes are then filled with
contrast media fluoroscopically imaged in a conventional manner. In
some cases, however, contrast media injected into the uterus does
not fully pass into the fallopian tubes. If the fallopian tubes are
not filled with the contrast media, subsequent imaging may be
inadequate.
In such circumstances, it has been proposed to pass a pair of
coaxial catheters through the uterine access catheter in order to
access the fallopian tubes. In particular, an outer catheter is
used to engage the fallopian os and a smaller tubular catheter is
passed through the outer catheter and into the fallopian tube.
Contrast media can then be injected directly into the fallopian
tube for improved imaging. Such systems are described in U.S. Pat.
No. 5,372,584.
While such coaxial catheter systems for selectively accessing the
uterus and fallopian tubes are generally successful, they rely on
using a relatively large diameter uterine access catheter. In
particular, the uterine access catheter must be sufficiently large
to pass the coaxial catheter system which is used to enter the
fallopian tubes. The need to pass a larger catheter through the
cervix significantly increases patient discomfort and can be more
difficult for the physician to insert. While it would be possible
to initially employ a small catheter for contrast media
introduction, subsequent fallopian tube access would then require
use of a second, larger uterine access catheter, thus increasing
the cost and complexity of the procedure.
A further deficiency of presently utilized uterine access systems
is the inability to or difficulty of manipulating the uterus during
the hysterosalpingography or other imaging procedure. Frequently,
it would be desirable to reorient the uterus to improve the
fluoroscopic image or for other purposes. While a variety of
uterine manipulating devices exist, most are incapable of fluid
injection for fluoroscopic imaging. While combination uterine
injectors and manipulators do exist, such as those available from
BEI Medical Systems, Inc., under the tradenames ZUMI AND ZUI (which
are generally described in U.S. Pat. No. 4,430,076), the handle
which is attached over the balloon catheter for engaging the
interior surface of the cervical os is difficult to properly
position over the inner balloon catheter. Moreover, the handle is
useful only for manipulation and does not provide uterine access
for the introduction of other uterine and/or fallopian catheters.
In contrast, the catheter system described in U.S. Pat. No.
5,372,584, is not useful for uterine manipulation. The '584
catheter has a disk which engages the outside of the cervix to
maintain a seal. While sufficient to provide the desired seal, if
the '584 catheter were used to manipulate the uterus, the seal
provided by the disk would be stressed and the seal lost.
For these reasons, it would be desirable to provide improved
apparatus and methods for accessing and manipulating the uterus in
hysterosalpingography and other procedures. Such apparatus and
methods will preferably provide for the introduction of a small
diameter balloon catheter having a sleeve catheter thereover, where
the assembly of the balloon catheter and sleeve catheter together
provides sufficient rigidity and column strength to permit
manipulation of the uterus and wherein the balloon catheter may be
withdrawn from the sleeve catheter to permit use of the sleeve
catheter for other purposes, such as the introduction of uterine
and/or fallopian tube catheters. Such apparatus and methods should
reduce the complexity and cost of performing hysterosalpingography
and other related uterine and fallopian tube access procedures. It
would further desirable if such apparatus were useful for other
gynecological procedures, such as treatment of proximal tubal
occlusion, endoscopic tubal examination, transcervical gamete
intrafallopian transfer (GIFT), therapeutic drug delivery for
treatment of infections and ectopic pregnancies, endometrial
biopsy, intrauterine ultrasound, and the removal of myomas, polyps,
and/or septums, and the like.
2. Description of the Background Art
U.S. Pat. No. 5,372,584, describes a catheter system for performing
hysterosalpingography and selective salpingography. Catheter
systems and methods for accessing the fallopian tubes are described
in U.S. Pat. Nos. 5,389,089; 5,379,247; 5,300,023; and 5,147,315.
Catheters intended for uterine access and/or manipulation are
described in U.S. Pat. Nos. 5,259,836; 5,104,377, 4,496,345;
4,430,076; and WO 96/22122. Other catheter systems are described in
U.S. Pat. Nos. 5,273,526 and 5,211,627. A cervical cannula is
described in SU 730355. Laparoscopic cannulas comprising coaxial
tubular members are described in U.S. Pat. Nos. 5,002,557 or
5,176,697. A cervical manipulator comprising an inner balloon
member and other cervical cap is described in U.S. Pat. No.
5,209,754. Devices manufactured under U.S. Pat. No. 4,430,076, are
sold by BEI Medical Systems under the trade name ZUMI, as described
in a catalogue of BEI.
A coaxial catheter system for accessing and imaging a fallopian
tube is described in copending application Ser. No. 08/207,475,
filed on Mar. 7, 1994, assigned to the assignee of the present
application, the full disclosure of which is incorporated herein by
reference.
SUMMARY OF THE INVENTION
According to the present invention, apparatus and methods are
provided for accessing, manipulating, and optionally imaging a
patient's uterus and fallopian tubes. The apparatus and methods are
particularly suitable for use during the performance of
hysterosalpingography where the uterus may be manipulated to
improve the image obtained or for other purposes. The apparatus and
methods further provide for accessing the fallopian tubes following
the hysterosalpingography, but would also find use in a variety of
other procedures requiring access to and manipulation of the
uterus.
The apparatus and methods are particularly advantageous in that
uterine access is provided by a small diameter, usually soft,
catheter which is passed through the cervical os into the uterus.
Uterine manipulation and subsequent catheter exchange are provided
by a second, sleeve catheter which is disposed over the small
diameter balloon catheter. The sleeve catheter has an atraumatic
occluding member at its distal end which directly engages the
interior surface of the cervical os. The occluding member is
preferably formed as an inverted cone or "adorn" seal which
partially penetrates and seals within the cervix in a manner that
permits manipulation without the loss of seal. Together, the inner
balloon catheter and sleeve catheter provide sufficient column
strength and rigidity so that the uterus can be manipulated from
the proximal end of the assembly of the two catheters. The
individual catheters, however, are sufficiently small and soft so
that the patient suffers minimum discomfort and trauma.
In a first aspect of the present invention, a uterine access
catheter system comprises an inner catheter and a sleeve catheter.
The inner catheter has a proximal end, a distal end, and a lumen
therebetween. An inflatable balloon is positioned near the distal
end of the inner catheter. The sleeve catheter has a proximal end,
a distal end, and a lumen therebetween, and is sized to slidably
receive the inner catheter therethrough. An occluding member is
disposed near the distal end of the sleeve catheter and is
configured to partially penetrate and seal against an anterior
surface of the cervical os when the balloon of the inner catheter
is positioned in the uterus. In particular, the sleeve catheter may
be advanced distally over the inner catheter to provide for the
desired engagement and seal. A locking mechanism is provided on the
catheter assembly so that the sleeve catheter may be selectively
fixed to the inner catheter to prevent relative axial movement
therebetween. In this way, after the inner catheter is introduced
and the balloon inflated, the sleeve catheter can be distally
advanced to engage the distal occluding member against the anterior
surface of the cervical os, providing a good seal and firm
mechanical anchor. The sleeve catheter may then be locked to
maintain such engagement and seal.
In a particular aspect of the access catheter system, both the
inner catheter and the sleeve catheter have dimensions and physical
characteristics selected to minimize patient trauma while
maintaining sufficient mechanical strength to permit uterine
manipulation. In particular, the inner catheter will have an
outside diameter in the range from 1 mm to 2.5 mm, preferably from
1.5 mm to 2 mm, a lumen diameter in the range from 0.5 mm to 1.5
mm, usually in the range from 0.5 mm to 0.8 mm, and a length in the
range from 25 cm to 40 cm. The sleeve catheter will preferably have
an outside diameter in the range from 3 mm to 4.5 mm, usually from
3.3 mm to 4 mm, a lumen diameter in the range from 2 mm to 4 mm,
usually from 2.5 mm to 3 mm, and a length in the range from 15 cm
to 25 cm, usually from 15 cm to 20 cm. It is particularly preferred
that the inner catheter be relatively soft, usually having a
hardness in the range from 65D to 75D, preferably from 68D to 74D.
The outer catheter will be somewhat harder, usually having a
hardness in the range from 65D to 100D, preferably from 70D to 80D.
By providing an inner catheter and sleeve catheter having
hardnesses within these ranges, the desired mechanical strength is
achieved without causing excessive patient discomfort or
trauma.
In a specific aspect of the uterine access catheter system of the
present invention, the occluding member on the sleeve catheter is
formed as a conical plug having its apical end disposed in the
distal direction. Optionally, the conical plug or other occluding
member may be removably attached to the distal end of the sleeve
catheter. Usually, the conical plug or other occluding member will
be a resilient structure having a generally fixed geometry (i.e.
not inflatable). In alternative embodiments of the present
invention, however, the occluding member can be an inflatable
balloon, usually having a similar conical configuration when
inflated.
In yet another specific aspect of the uterine access catheter
system of the present invention, the lock is configured to
selectively fix a distal portion of the sleeve catheter to a distal
portion of the inner catheter. By locking the inner catheter and
sleeve catheter together near their respective distal ends,
engagement of the cervix between the balloon and the occluding
member may be enhanced. While the present invention contemplates
that the catheter lock may be at any axial location within the
catheter system, including near the proximal ends, locking
mechanisms positioned at or near the proximal end will provide less
locking rigidity between the distal ends of the catheters, and is
therefore less preferred. Thus, it is preferred that the locking
mechanism be dispersed to lock the inner matter to the sleeve
catheter in a region within the distal-most 10 cm of the sleeve
catheter, more preferably being within the distal-most 5 cm.
In the exemplary embodiment of the catheter lock, a feature is
formed on an exterior surface of the inner catheter which
selectively engages a mating feature on an inner surface of the
sleeve catheter. For example, the feature on the exterior surface
of the inner catheter may be a protrusion and the feature on the
inner surface of the sleeve catheter may be a recess. After axially
aligning the surface features, the catheters can be locked and
unlocked to one another to be simply rotating the catheter to move
the protrusion(s) and recess(es) in and out of engagement.
In a further specific aspect of the access catheter system in the
present invention, the sleeve catheter may further comprise an
exterior seal which seals over the interior surface of the cervix
when the occluding is in the cervical os. Such a sealing member is
particularly useful when the catheter system is provided with a
vacuum connector which permits application of a vacuum between the
occluding member and the balloon on the inner catheter when the
cervix is being engaged therebetween. Application of such a vacuum
acts to draw the occluding member into the cervical os, further
enhancing engagement and sealing.
In other specific aspects of the uterine access catheter system of
the present invention, the inner catheter may further include a hub
at its proximal end, and the sleeve catheter may be introduced and
removed over the distal end of the inner catheter. Usually, the
distal balloon on the inner catheter is elastomeric and can be
inflated to a width in the range from 10 mm to 15 mm. The system
may further be provided with a stiffening rod that is removably
received in the lumen of the inner catheter to facilitate
introduction of the inner catheter through the cervical os at the
initial stage of a procedure. The stiffening rod may be resilient
or may be malleable. Malleable stiffening rods are less traumatic
and permit the physician to shape the stiffening rod according to
the anatomy of a particular patient. Usually, the sleeve catheter
will further include a handle or hub at its proximal end, and more
usually the handle will comprise a connective fitting, such as a
luer fitting.
In a second aspect of the present invention, methods for accessing
the uterus comprise providing a catheter assembly generally as
described above. The catheter assembly is introduced through the
patient's vagina so that the balloon on the inner catheter is
positioned past the cervix and lies within the uterus. The
occluding member on the sleeve catheter is then engaged against an
interior surface of the cervix, and the balloon inflated to seal
against a posterior surface of the cervix. Usually, the balloon
will be inflated first to facilitate advancing the occluding member
against the cervix. After adequate engagement has been achieved,
the sleeve catheter is locked to the inner catheter to prevent
relative axial movement.
The catheter assembly introduced and anchored in place as described
above is particularly useful for manually manipulating the position
of the uterus during hysterosalpingography procedures or for other
reasons. Such manual manipulation is achieved by moving the
proximal end of the catheter assembly, where the manipulative
forces are transmitted through the catheter assembly to the cervix
and to within the uterus. The combined column strengths of the
inner catheter and the sleeve catheter enhance such force
transmission. The preferred dimensions and physical properties of
the catheters are set forth above.
In a particularly preferred aspect of the method of the present
invention, the locking step comprises rotating the inner catheter
relative to the sleeve catheter to selectively engage a surface
feature on the inner catheter with a surface feature on the outer
catheter. By rotation, it is meant that at least one of the two
catheters is rotated about its longitudinal axis relative to the
other catheter. Of course, both catheters could be rotated in
opposite directions until the desired engagement in locking is
achieved. The catheters may then be disengaged by further rotating
one catheter relative to the other. The preferred locking
mechanisms utilized in the method are described above in connection
with system.
Optionally, contrast media is introduced through the inner catheter
into the uterus and imaging performed in a hysterosalpingography
procedure. After such imaging, the catheters may be unlocked and
the inner catheter withdrawn, leaving the sleeve catheter in place.
A uterine catheter may then be introduced through the lumen of the
sleeve catheter and guided to a fallopian tube falloposcope which
can then be guided through the uterine catheter into the fallopian
tube and the fallopian tube imaged. Alternatively, contrast media
can be introduced through the fallopian tube catheter and the
fallopian tube imaged by fluoroscopy. In yet another specific
aspect of the method of the present invention, sealing between the
occluding member on the sleeve catheter and the anterior surface of
the cervical os may be enhanced by drawing a vacuum between the
inflated balloon on the inner catheter and the occluding member.
Optionally, the ability to draw the vacuum may be enhanced by
positioning a seal over the exterior of the cervix before drawing
the vacuum.
In still yet another specific aspect of the method of the present
invention, the occluding member may be removed from the sleeve
catheter after use, sterilized, and reused.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a uterine access catheter system
constructed in accordance with the principles of the present
invention.
FIG. 1A is a detailed view with portions broken away of a portion
of the sleeve catheter over the inner catheter of the catheter
system of FIG. 1, showing a preferred locking mechanism.
FIG. 1B is a cross-sectional view taken along line 1B--1B of FIG.
1A.
FIG. 1C is a cross-sectional view similar to that of FIG. 1B,
except that the inner catheter and sleeve catheter have been
rotated so that the locking mechanism is out of engagement.
FIG. 2 is an exploded view of the catheter system of FIG. 1.
FIG. 2A is a detailed view of an alternative mounting mechanism for
a removable occluding member of the sleeve catheter of the catheter
system of FIG. 1.
FIG. 2B illustrates an alternative occluding member for the sleeve
catheter of the catheter system of FIG. 1, in the form of an
inflatable balloon.
FIGS. 3A-3E illustrate use of the catheter system of FIG. 1 for
performing uterine manipulation and a hysterosalpingography
procedure followed by accessing the fallopian tube with a fallopian
catheter.
FIGS. 4-6 illustrate a modification to the sleeve catheter of the
catheter system of FIG. 1 where an exterior cervical seal and
vacuum connection are provided.
DETAILED DESCRIPTION OF THE SPECIFIC EMBODIMENTS
A uterine access catheter system according to the present invention
is illustrated in FIGS. 1, 1A-1C, and 2. The catheter system 10
comprises two major components, the first of which is an inner
catheter 12 having a proximal end 14, a distal end 16, and an
inflatable balloon 18 near the distal end. A proximal hub 20 is
secured to the proximal end 14 of the inner catheter 12 and
includes an inflation port 22 and an axial lumen access port 24.
Typically a luer fitting 26 will be located at the proximal end of
the proximal hub 20.
The inner catheter 12 preferably comprises a flexible body formed
from a soft material, usually a soft thermoplastic polymer or
elastomer, such as a polyether block amide (pebax) having a
hardness in the range set forth above. The inner catheter 12 will
include an axial access lumen 28 and usually a separate inflation
lumen (not shown) extending between inflation port 22 and the
balloon 18. The access lumen 28 will permit introduction of
contrast media to the uterus, as will be described hereinafter.
Additional lumens may also be provided, although there will usually
be no additional lumens since it is desired to maintain a low
profile for the inner catheter to facilitate entry through the
cervical os. The preferred dimensions of the inner catheter 12 are
set forth above.
The balloon 18 will usually be distensible, more usually being
formed from an elastomeric material, optionally being formed from
the same material as that used to form the catheter 12 itself. A
useful balloon material is polyethylene. The balloon will have
dimensions selected to permit inflation within the uterus on the
posterior side of the cervical os, usually having a width in the
range from 10 mm to 15 mm when fully inflated, more usually being
generally spherical.
The second major component of the uterine access catheter system of
the present invention is a sleeve catheter 30 which is usually in
the form of a simple tube having only a single lumen therethrough
and an occluding member 31 positioned at its distal end.
Optionally, although not necessarily, a handle which may be in the
form of a luer fitting 36 is secured to the proximal end 32 of the
sleeve catheter 30.
The occluding member 31 may be fixedly attached to the distal end
of the sleeve catheter 30, but will usually be removably attached
thereto. For example, the occluding member 31 may be removably
secured to the sleeve catheter 30 by a conventional threaded
fitting, as illustrated in FIG. 2, or may be secured to the sleeve
catheter by spring-loaded balls 33 in the occluding member 31 and
corresponding detents 35 on the distal end of the sleeve catheter
30, as illustrated in FIG. 2A. As yet another alternative, the
occluding member 31 can be an inflatable balloon 31a, as
illustrated in FIG. 2B, where the inflated configuration is
illustrated in broken line. It will be appreciated that the form of
the occluding member is not critical so long as it can be
selectively engaged against and sealed to the anterior side of the
cervical os to permit both manipulation and fluid introduction
according to the method of the present invention. Preferably, the
geometry will be conical with the apical end disposed distally to
partially penetrate and seal against the cervical os.
Referring now in particular to FIGS. 1A-1C, the preferred locking
mechanism for the coaxial catheters of the catheter system 10 of
the present invention will be described. A plurality of protrusions
41 are formed on the outer surface of inner catheter 12. The
protrusions 41 may be in any form, but are preferably formed as
small wedges or chevrons which engage similarly shaped recesses 43
formed in the inner surface of the sleeve catheter 30. Preferably,
a plurality of protrusions 41 will be axially aligned over one or
more lines on the exterior surface of the inner catheter 12. Most
preferably, there will be two such lines on opposite sides of the
outer surface of the inner catheter 12. In this way, the inner
catheter 12 and sleeve catheter 30 can be rotated relative to one
another so that the protrusions 41 line up with the recesses 43, as
illustrated in FIG. 1B, to lock the catheters together. The
catheters can be unlocked simply by rotating the catheters further
so that the protrusions 41 fall out of alignment with the recesses
43, as illustrated in FIG. 1C. Usually, more recesses will be
provided on the interior surface of the sleeve catheter 30,
permitting locking over a range of axial positions. By orienting
the wedge-shaped protrusions with the ramped surface declining in
the distal direction, as illustrated in FIG. 1A, particular
strength is provided to draw proximally on the catheter assembly to
manipulate the uterus. Disengagement can be then facilitated by
advancing the inner catheter 12 relative to the sleeve.
A stiffening rod or mandrel 40 is optionally provided for inserting
through the lumen 28 of the inner catheter 12. The stiffening rod
40 improves the column strength of the inner catheter 12 to
facilitate initial introduction through the cervix. After
introduction, the stiffening rod 40 can be removed to clear the
lumen for introduction of contrast media to perform
hysterosalpingography or other procedures. The stiffening rod 40
may be composed of a malleable material, such as stainless
steel.
The components of the uterine access catheter system 10 may be
packaged separately, but will often be packaged together in a
sterile package, such as a pouch, box, or other conventional
packaging for medical devices. The uterine access catheter system
may be used with other conventional and commercially available
catheters for performing fallopian tube access, as described
hereinbelow.
Use of the uterine access catheter system 10 of the present
invention for performing hysterosalpingography and manipulating the
uterus will now be described in connection with FIGS. 3A-3D.
Initially, the access catheter assembly 10 is introduced through
the vaginal opening V so that balloon 18 is disposed past cervix C.
The balloon is then inflated within the uterus U in order to block
outflow from the uterus through the cervix C, as illustrated in
FIG. 3A. After appropriately positioning the inner catheter 12, the
sleeve catheter 30 is advanced distally over the inner catheter 12
until the occluding member 31 engages an anterior surface of the os
of cervix C, as illustrated in FIG. 3B. After the physician feels
that the cervical os has been firmly captured between the balloon
18 and the occluding member 31, the sleeve catheter 30 will be
locked to the inner catheter 12 by rotating one relative to the
other, as described above.
At this point, the catheter assembly is ready either for
introduction of contrast media or other fluids through the inner
catheter 12 or for manipulation of the uterus using the combined
inner catheter 12 and outer sleeve catheter 30. Fluid introduction
is achieved through the fluid infusion port 24 on inner catheter
12. Manipulation is achieved by the physician manually grasping a
proximal portion of the catheter, typically near the handle 36 of
sleeve catheter 30 and moving the assembly until the uterus is
positioned in a desired manner.
After the initial hysterosalpingography or other procedures
completed, the sleeve catheter 30 may be utilized for introduction
of other fluid media or other catheters by first removing the inner
catheter 12. Such removal is accomplished by rotating the inner
catheter relative to the sleeve catheter 30 until they are
disengaged. Balloon 18 is deflated, and the inner catheter is
withdrawn proximally through the lumen of sleeve catheter 30,
resulting in positioning of the sleeve catheter 30 as shown in FIG.
3C. Fluids can be introduced by attaching to the luer fitting 36.
Alternatively, a uterine access catheter 50 may be positioned
through the lumen of the sleeve catheter 30 into the uterus U, as
shown in FIG. 3D. Suitable uterine access catheters are available
from commercial suppliers, such as Conceptus, Inc., San Carlos,
Calif., under the trade name SOFT TORQUE.TM.. The uterine catheter
50 is positioned so that a deflected end 52 lies adjacent the os of
the fallopian tube FT. The uterine catheter 50 thus provides a
secondary access lumen directly to the os.
After the uterine catheter 50 has been positioned, a fallopian
catheter 60 is passed through the uterine catheter 50, as
illustrated in FIG. 3E. Optionally, a guidewire (not illustrated)
may be used to position the fallopian catheter 60 within the
fallopian tube FT. The fallopian catheter 60 may then be used to
provide improved imaging of the fallopian tube. For example,
contrast media may be directly injected through the fallopian
catheter 60 into the fallopian tube, and fluoroscopic imaging of
the tube performed. Alternatively, a falloposcope (not shown) may
be introduced through the fallopian catheter 60 and used to image
the fallopian tube. Such catheters are commercially available from
Conceptus, Inc. under the trade name VS.TM. catheter. Use of such
falloposcopes for imaging a fallopian tube is described in
copending application Ser. No. 08/207,475, the full disclosure of
which has been previously incorporated herein by reference. The
fallopian catheter may be used for other purposes, including
treatment of proximal tubal occlusions, and transcervical gamete
intrafallopian transfer (GIFT), therapeutic drug delivery for
treatment of infectious and ectopic pregnancies, and endometrial
biopsy, intrauterine ultrasound, removal of myomas, polyps, and/or
septums and the like.
Referring now to FIGS. 4-6, an alternative embodiment of the sleeve
catheter of the catheter system of the present invention will be
described. Sleeve catheter 50 comprises an inner tubular member 52
and an outer tubular member 54. The inner tubular member 52 and
outer tubular member 54 are arranged coaxially and may be axially
translated relative to each other. An occluding member 56 is
mounted at the distal end of the inner tubular member 52. A conical
cup member 60 is disposed at the distal end of the outer tubular
member 54. A flexible seal 62 extends from the distal end of cup 60
to the proximal end of the occluding member 56. By advancing the
outer tubular member 54 distally relative to the inner tubular
member 52, the flexible seal 62 may be everted, as shown in FIG. 6.
In particular, the seal 62 may be everted so that it can engage and
seal to the exterior of cervix C to enhance the sealing achieved on
the anterior surface of the exterior os. Such sealing may be
further enhanced by drawing a vacuum within the cervix C,
conveniently by attaching a vacuum source to connector 70 which
opens to the annular lumen between the inner luminal surface of
inner tubular surface of inner tubular member 52 and the outer
surface of inner catheter 12, as shown in FIG. 6. Typically, an
"O-ring" or other appropriate seal will be provided distally of the
vacuum connector 70 so that a vacuum can be drawn. Drawing a vacuum
will further engage both the occluding member 56 and the seal 62
onto the cervix, assuring a fluid tight seal. Such application of a
vacuum further enhances the mechanical engagement of the catheter
system to the cervix, facilitating manipulation of the uterus as
described previously.
Although the foregoing invention has been described in some detail
by way of illustration and example, for purposes of clarity of
understanding, it will be obvious that certain changes and
modifications may be practiced within the scope of the appended
claims.
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